Vonoprazan-2001 - GERD study
Research type
Research Study
Full title
A Randomized, Double-Blind, Proof-of-Concept, Phase 2 Study to Evaluate the Efficacy and Safety of Once Daily Oral Vonoprazan 20 mg or Vonoprazan 40 mg Compared to Esomeprazole 40 mg for the Treatment of Subjects With Symptomatic Gastro Esophageal Reflux Disease Who have a Partial Response Following Treatment with a High Dose of Proton Pump Inhibitor
IRAS ID
199031
Contact name
Timothy Bray
Contact email
Sponsor organisation
Takeda Development Center Europe Ltd
Eudract number
2015-001154-14
Duration of Study in the UK
1 years, 2 months, 28 days
Research summary
The purpose of this research study is to compare the effectiveness of two treatments which block acid secretion in the stomach, vonoprazan and esomeprazole, for the prevention of heartburn symptoms in subjects who have a diagnosis Gastro-Esophageal Reflux Disease (GERD) and who have a partial response (still have symptoms) to treatment with proton pump inhibitors.\n \nSymptomatic GERD may cause problems in patients and result in troublesome symptoms such as heartburn (a burning feeling in the mid-epigastric area) or regurgitation (sour or bitter fluid in the mouth) as the stomach contents move upwards out of the stomach.\n\nVonoprazan is an “investigational” drug, which means it has not been approved by the MHRA and is not available as a prescription or over-the-counter medicine. Esomeprazole has already been approved for the treatment of (GERD) in the UK and other countries. \n\nParticipants may be involved in the study for up to 12 weeks and it will include 6 visits to the study centre and 1 telephone safety call. There will be 213 patients taking part in this study at up to 50 study clinics in Europe. Approximately 24 subjects in the UK will be enrolled into this study.\n
REC name
London - Westminster Research Ethics Committee
REC reference
16/LO/0285
Date of REC Opinion
23 May 2016
REC opinion
Further Information Favourable Opinion